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Class 2 Device Recall INNOMED CUP REMOVAL STARTER INSTRUMENT |
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| Date Initiated by Firm |
March 07, 2024 |
| Date Posted |
May 01, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1753-2024 |
| Recall Event ID |
94337 |
| Product Classification |
Extractor - Product Code HWB
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| Product |
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup |
| Code Information |
UDI/DI 00840277104007, Lot Number 1223K |
Recalling Firm/
Manufacturer |
Innomed, Inc.
103 Estus Dr
Savannah GA 31404-1445
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| For Additional Information Contact |
Irene Davis
912-236-0000 Ext. 112
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Manufacturer Reason
for Recall |
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
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FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
Innomed issued an urgent medical device recall notice to its consignees on 03/07/2024 via email. The notice explained the issue, potential risk to health, and requested the return of the affected devices for US distribution and destruction of the affected devices distributed outside the US. |
| Quantity in Commerce |
41 devices |
| Distribution |
FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada
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| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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